credits bmbl December 7 '06.doc - Central Michigan University

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23. Robinson JP. Annex 2. Toxins. In: Public health response to biological and chemical weapons: WHO guidance. 2nd edition. Geneva: World Health Organization; 2004. p. 214-28. 414
Appendix J NIH Oversight of Research Involving Recombinant Biosafety Issues The NIH locus for oversight of recombinant DNA research is the OBA, which is located within the Office of Science Policy, in the Office of the Director of the NIH. The OBA implements and manages the various oversight tools and information resources that NIH uses to promote the science, safety and ethics of recombinant DNA research. The key tools of biosafety oversight are the NIH Guidelines, IBCs, and the RAC. The NIH also undertakes special initiatives to promote the analysis and dissemination of information key to our understanding of recombinant DNA, including human gene transfer research. These initiatives include a query-capable database and conferences and symposia on timely scientific, safety, and policy issues. The NIH system of oversight is predicated on ethical and scientific responsibilities, with goals to promote the exchange of important scientific information, enable high-quality research, and help advance all fields of science employing recombinant DNA. The NIH Guidelines promote safe conduct of research involving recombinant DNA by specifying appropriate biosafety practices and procedures for research involving the construction and handling of either recombinant DNA molecules or organisms and viruses that contain recombinant DNA. Recombinant DNA molecules are defined in the NIH Guidelines as those constructed outside of a living cell by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell. The NIH Guidelines are applicable to all recombinant DNA work at an institution that receives any funding from the NIH for recombinant DNA research. Compliance with the NIH Guidelines is mandatory for investigators conducting recombinant DNA research funded by the NIH or performed at or sponsored by any public or private entity that receives any NIH funding for recombinant DNA research. This broad reach of the NIH Guidelines is intended to instill biosafety practices throughout the institution, which is necessary if the practices are to be effective. The NIH Guidelines were first published in 1976 and are revised as technological, scientific, and policy developments warrant. They outline the roles and responsibilities of various entities associated with recombinant DNA research, including institutions, investigators, biological safety officers, and the NIH (see Section IV of the NIH Guidelines). They describe four levels of biosafety and containment practices that correspond to the potential risk of experimentation and require different levels of review for recombinant DNA research, based on the nature and risks of the activity. These include: 1. Review by the RAC, and approval by the NIH Director and the IBC. 2. Review by the NIH OBA and approval by the IBC. 3. Review by the RAC and approvals by the IBC and Institutional Review Board. 415
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Biosafety in Microbiological and Bi
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SECTION VIII-H: Prion Diseases 299
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Forward Biosafety in Microbiologica
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Editors: L. Casey Chosewood, MD Dir
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Guest Editors: Matthew J. Arduino,
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Charles B. Millard, PhD Lieutenant
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Robert Bull Karen B. Byers Jane Cap
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Thomas L. Miller Douglas M. Moore M
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Robert Yarchoan Uri Yokel Lisa Youn
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Introduction laboratories chose not
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Introduction RISK CRITERIA FOR ESTA
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Introduction BMBL includes an impor
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Section II Biological Risk Assessme
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Biological Risk Assessment informat
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Biological Risk Assessment The NIH
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Biological Risk Assessment effectiv
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Biological Risk Assessment Third, m
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Biological Risk Assessment 14. Oxma
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Principles of Biosafety Safety equi
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Principles of Biosafety Often an in
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Principles of Biosafety Four standa
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Principles of Biosafety 4. Centers
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Laboratory Biosafety Level Criteria
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Section V Vertebrate Animal Biosafe
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Vertebrate Animal Biosafety Level C
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TABLE 1 SUMMARY OF RECOMMENDED BIOS
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Principles of Laboratory Biosecurit
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Occupational Health and Immunoproph
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Agent Summary Statements - Bacteria
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• Section VIII-B: Fungal Agents A
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Agent Summary Statements - Fungal A
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• Section VIII-C: Parasitic Agent
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Agent Summary Statements - Parasiti
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Agent Summary Statements - Ricketts
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Agent Summary Statements - Ricketts
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• Section VIII-E: Viral Agents Ag
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Agent Summary Statements - Viral Ag
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Agent Summary Statements - Arboviru
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• Section VIII-G: Toxin Agents Se
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Agent Summary Statements - Toxins i
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Agent Summary Statements - Toxins A
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Agent Summary Statements - Toxins L
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Agent Summary Statements - Toxins t
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• Section VIII-H: Prion Diseases
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Agent Summary Statement - Prion Dis
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Appendix A Proper maintenance of ca
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Appendix A declined. However, in ma
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Appendix A It is possible to exhaus
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Appendix A 4. The Class II, Type A2
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Appendix A prohibited. Furthermore,
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Appendix A plastic wrappers, pipett
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Appendix A touch-plate microburners
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Appendix A SECTION VI FACILITY AND
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Appendix A Development of Containme
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Appendix A C. Airflow Smoke Pattern
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Appendix A TABLES Table 1. Selectio
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Appendix A Table 3. Field Performan
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Appendix A FIGURES Figure 1. HEPA f
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Appendix A Figure 3. The Class II,
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Appendix A Figure 5B. The Class II,
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Appendix A Figure 8. The Class III
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Appendix A Figure 9B. The vertical
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Appendix A Figure 11. A typical lay
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Appendix A REFERENCES 1. Centers fo
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Appendix B Decontamination and Disi
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Appendix B surfaces are contaminate
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Appendix B TABLE 1 DESCENDING ORDER
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Appendix B dioxide gas exits the ge
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Appendix B d The effectiveness of a
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Appendix C Transportation of Infect
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Appendix C 1600 Clifton Road, N.E.,
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Appendix C disease in humans or in
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Appendix C Biological specimen, Cat
Page 363 and 364: Appendix D Agriculture Pathogen Bio
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Page 369 and 370: Appendix D Wastes and other materia
Page 371 and 372: Appendix D Camelpox virus b a, b, c
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Page 381 and 382: Appendix D five day period of conta
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Page 391 and 392: Appendix D Spring Viremia of Carp V
Page 393 and 394: Appendix D REFERENCES 1. Hess WR. A
Page 395 and 396: Appendix D 37. Alexander DJ. Newcas
Page 397 and 398: Appendix E Arthropod Containment Gu
Page 399 and 400: Appendix F Select Agents and Toxins
Page 401 and 402: Appendix G IPM issues and requireme
Page 403 and 404: Appendix H Working with Human, NHP
Page 405 and 406: Appendix I Guidelines for Work with
Page 407 and 408: decontaminated periodically, for ex
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Page 411 and 412: k Irradiation causes a dose-depende
Page 413: 7. Morin R, Kozlovac J. Biological
Page 417 and 418: Appendix K Resources for Informatio
Page 419 and 420: Appendix K E-mail: http://www2.gsu.
Page 421 and 422: Appendix K and http://www.who.int/c
Page 423 and 424: Appendix L HEPA High Efficiency Par
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